BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML SYRINGE

    MDR report key: 8601163 · Received May 10, 2019

    Report

    Report Number
    3002682307-2019-00297
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE FOR CATALOG 300928 LOT 1811147 TO INVESTIGATE FOR THIS RECORD. AFTER THE EVALUATION OF THE RETURNED SAMPLE, THE FOREIGN MATTER WAS IDENTIFIED AS EMBEDDED CONTAMINATION IN THE PLUNGER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE EMBEDDED PARTICLES DEFECT WAS PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), SOME PARTICLES OF PLASTIC AND REST OF OIL FROM THE POLYETHYLENE CAN REMAIN STUCK ON THE INTERNAL WALLS OF THE MOLD AND GET BURNT. DURING NORMAL PRODUCTION SOME PARTICLES MAY BE DETACHED FROM THE SCREW BEING INJECTED AND REMAINING EMBEDDED IN MOLDED PIECE. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE NEEDLE HUB WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE GREY STAINS, SIMILAR TO MOLD WITH A BD DISCARDIT¿ II 2 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE SYRINGE PLUNGER HAS BLACK GREY STAINS, SIMILAR TO MOULD AT THE NEW, NOT USED PRODUCT IN THE UNDAMAGED PACKAGING.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE GREY STAINS, SIMILAR TO MOLD WITH A BD DISCARDIT¿ II 2 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE SYRINGE PLUNGER HAS BLACK GREY STAINS, SIMILAR TO MOULD AT THE NEW, NOT USED PRODUCT IN THE UNDAMAGED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391782 BD DISCARDIT II 2 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other